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Prostate cancer
updates
AHMED M. TAWFEEK
Don’t judge the presenter judge the material
Gleason score

    The Gleason score is the sum of the two most common patterns
     (grades 1-5) of tumour growth found. The Gleason score ranges
     between 2 and 10, with 2 being the least aggressive and 10 the
     most aggressive.


    In needle biopsies, the worst grade should always be incorporated
     in the Gleason score, even if comprising < 5% of the cancer.


    During the past 20 years, there appears to have been a shift
     towards higher Gleason scoring levels ,even in cases evaluating
     microscopic foci of PCa. Some tumours previously given a Gleason
     score of 6 (3 + 3) might be scored today as 7 (3 + 4) or higher.
SCREENING AND EARLY DETECTION

    Based on the results of these two large, randomised trials, (PLCO)
     (ERSPC) most if not all of the major urological societies conclude
     that at present widespread mass screening for PCa is not
     appropriate. Rather, early detection (opportunistic screening)
     should be offered to the well-informed man


    Two key questions remain open:


 • At what age should early detection start?


 • What is the screening interval for PSA and DRE?
   A baseline PSA determination at age 40 years has been suggested,
    upon which the subsequent screening interval may then be based
    (GR: B).


   A screening interval of 8 years might be enough in men with initial
    PSA levels <1 ng/mL .


   PSA testing in men older than 75 years is not recommended
    because its early detection would not have any clinical impact .
DIAGNOSIS

    The main diagnostic tools to obtain evidence of PCa include
     DRE, serum concentration of PSA and transrectal ultrasonography
     (TRUS). Its definite diagnosis depends on the histopathologic
     verification of adenocarcinoma


    Sextant biopsy is no longer considered adequate. At a glandular
     volume of 30-40 mL, at least eight cores should be sampled. The
     British Prostate Testing for Cancer and Treatment Study has
     recommended 10 core biopsies (LE: 2a)


    More than 12 cores are not significantly more conclusive (LE: 1a)
Endorectal MRI (e-MRI)

    may allow for more accurate
     local staging as Image quality
     and localization      improves
     significantly with e-MRI , When
     compared with DRE and TRUS.
   e-MRI contributes significant incremental value for local PCa staging
    ,particularly in the pre-operative identification of extraprostatic
    extension (EPE) and seminal vesicle invasion (SVI).


   e-MRI could impact on the decision to preserve or resect the
    neurovascular bundle (NVB) at the time of radical surgery
TREATMENT:
DEFERRED TREATMENT
    There is a great difference between the incidence of PCa and
     deaths from Pca


    Several autopsy studies of people dying from different causes have
     shown that while 60-70% of older men have histological PCa, a large
     proportion of these tumours will not progress.


    The incidence of small, localised, well-differentiated PCa is
     increasing, mainly as a result of prostate-specific antigen (PSA)
     screening and ‘multicore’ schemes of prostate biopsy
   These data suggest that many men with localised PCa would not
    actually benefit from definitive treatment.


   With the aim of reducing the risk of overtreatment in this subgroup of
    patients, two conservative management strategies of ‘watchful
    waiting’ and ‘active surveillance’ have been proposed.
Watchful waiting (WW)
localised PCa (stage T1-T2, Nx-N0, M0)

      the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4)
       randomised 695 patients with clinical stage T1-T2 to WW (348) or
       radical prostatectomy (347) .


      This study began after PSA screening was introduced into clinical
       practice, but only 5% of men were diagnosed by screening.
   After a median follow-up of 12.8 years, this study showed a
    significant decrease in cancer-specific mortality, overall mortality,
    metastatic risk progression and local progression in patients treated
    with radical prostatectomy versus WW (LE: 1b).


   Subgroup analysis showed that the overall difference was not
    modified by PSA level (below or above 10 ng/mL) or by the Gleason
    score (below 7 or above) at the time of diagnosis.


   However, age at that the time of randomisation had a profound
    impact, the benefit on overall survival and metastases free survival
    being only seen for those below 65 years of age.
    The Prostate Cancer Intervention Versus Observation Trial:
    VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT) is an
    ongoing, controlled, multicentre, randomised clinical trial
    comparing radical prostatectomy with WW in patients with clinical
    stage T1-T2 disease.
   731 patients with a median age of 67 years were enrolled.
   approximately 43% of men had low-risk PCa, 36% had medium-risk
    PCa, and 20% had high-risk PCa.
   Follow-up is planned for 15 years, and the primary endpoint is the
    overall mortality.
   Preliminary unpublished results have been presented at the latest
    AUA meeting .
   The results suggested that overall there was a lack of survival
    benefit.
   However, there appeared to be an overall survival benefit in men
    with an intermediate- and high-risk PCa, as well as a cancer specific
    survival benefit in men with high-risk PCa or with a PSA above 10
    ng/mL.
   It appears that many small localised well-differentiated PCas will not
    progress, and radical therapy may lead to substantial
    overtreatment with resulting effects on the patients’ quality of life
    and treatments costs.
Active surveillance

    A variety of additional studies on active surveillance in clinically
     organ confined disease have now been published.
   All have confirmed that, in well-selected patients with very low-risk
    disease, there was a very low rate of progression and cancer-
    specific death, with only a few patients required delayed radical
    intervention.
   However, an extended follow-up is necessary to obtain definitive
    results.
   Thus, active surveillance might mean no treatment at all for patients
    older than 70 years, while in younger patients, it might mean a
    possible treatment delayed for years.
Indications

    Stage T1a: well and moderately differentiated tumours. In younger
     patients with a life expectancy of more than 10 years, re-evaluation
     with PSA, TRUS and biopsies of the prostatic remnant is
     recommended. (LE 2a)
    Stage T1b-T2b: well and moderately differentiated tumours. In
     asymptomatic patients with a life expectancy of < 10 years. (LE 2a)


    In patients with the lowest risk of cancer progression: T1-2a, PSA <10
     ng/mL, biopsy Gleason score <6 (at least 10 cores), <2 positive
     biopsies, minimal biopsy core involvement (<50% cancer per
     biopsy). (LE 2a)
   Active surveillance selection is based on confirmatory biopsies.


   Follow-up is based on DRE, PSA and repeated biopsies. The optimal
    timing for follow-up is still unclear (yearly or every 2 years).


   The trigger for patients being moved off active treatment is based
    mainly on grade progression on repeated biopsies or at the
    patient’s request.
ACTIVE MANAGMENT

    Management decisions should be made after all treatments have
     been discussed by a multidisciplinary team (including urologists,
     radiation oncologists, medical oncologists and radiologists), and
     after the balance of benefits and side effects of each therapy
     modality has been considered by the patients with regard to their
     own individual circumstances.
    Patient must be informed about the likelihood of a multimodal
     approach. In case of adverse tumour characteristics (positive
     section margin, extraprostatic extension, or seminal vesicle invasion),
     adjuvant radiotherapy may reasonably be used after recovery from
     surgery.
    When nodal involvement is detected after surgery, adjuvant ADT
     may be selected.
When it comes to Pca treatment it is a matter of perspective
RADICAL PROSTATECTOMY

    While it is the recommended choice In patients with low and
     intermediate risk localised PCa (cT1a-T2b and Gleason score 2-7
     and PSA <20 ng/mL) and life expectancy > 10 years. (LE1b)
    It is optional in Patients with stage T1a disease and a life expectancy
     >15 years or Gleason score 7. (LE 3)
    Selected patients with low-volume, high-risk, localised PCa (cT3a or
     Gleason score 8-10 or PSA > 20 ng/mL). (LE 3)
    Highly selected patients with very-high-risk, localised PCa (cT3b-T4
     N0 or any T N1) in the context of multimodality treatment.
neoadjuvant and adjuvant hormonal
treatment and radical prostatectomy
    NHT before RP does not provide a significant OS advantage over
     prostatectomy alone.
    NHT before RP does not provide a significant advantage in DFS over
     prostatectomy alone.
    NHT before RP does substantially improve local pathological
     variables such as organ-confined rates, pathological down-staging,
     positive surgical margins, and rate of lymph node involvement.
    Adjuvant HT following RP shows no survival advantage at 10 years.
    Adjuvant HT following RP: the overall effect estimate for DFS is highly
     significantly in favour of the HT arm.
DEFINITIVE RADIATION THERAPY

    There are no randomised studies comparing radical prostatectomy
     (RP) with either external beam radiation therapy (EBRT) or
     brachytherapy for localised PCa.
    However, the National Institutes of Health (NIH) consensus set up
     in1988 remains available: external irradiation offers the same long-
     term survival results as surgery.
    moreover, EBRT provides a QoL at least as good as that provided by
     surgery.
    Intensity modulated radiotherapy (IMRT) +/- image guided (IGRT) is
     the gold standard .
   three-dimensional conformal radiotherapy (3D-CRT)
   Anatomical data, acquired by scanning the patient in a treatment
    position, are transferred to the 3D treatment planning system, which
    visualises the clinical target volume and then adds a (surrounding)
    safety margin. At the time of irradiation,
   Intensity modulated radiotherapy(IMRT)
   enables radiation oncologists to increase radiation doses, up to as
    much as 86 Gy within the target volume, while respecting the
    tolerance doses in organs at risk. Certainly, IMRT is the only safe
    means of treatment delivery for dose escalation beyond 75 Gy
Immediate and delayed post-operative
external irradiation after radical prostatectomy

     Three prospective randomised trials have assessed the role of
      immediate post-operative radiotherapy
     The EORTC study 22911
     The study concludes that immediate post-operative radiotherapy
      after surgery significantly improved 5-year clinical or biological
      survival: 72.2% versus 51.8% (p < 0.0001)
     Also the ARO trial 96-02 and the SWOG 8794 trial with similar
      conclusion
   Either immediate radiotherapy (ART) to the surgical bed upon
    recovery of urinary function ; or clinical and biological monitoring
    followed by salvage radiotherapy (SRT) before the PSA exceeds 0.5
    ng/mL .


   Early salvage radiotherapy provides the possibility of cure to
    patients with an increasing or persisting PSA after RP.


   More than 60% of patients who are treated before the PSA level rises
    to more than 0.5 ng/mL will achieve an undetectable PSA level
    again
Recommendations regarding
radiation therapy
    In localized prostate cancer T1c-T2c N0 M0, 3D-CRT with or without
     IMRT is recommended, even for young patients who refuse surgical
     intervention. (LE 2)
    For high-risk patients, long-term ADT prior to and during radiotherapy
     is recommended because it results in increased overall survival.(LE 2)
    In patients with pathological tumour stage T3 N0 M0, immediate
     post-operative external irradiation after RP may improve overall
     survival and biochemical and clinical disease-free survival with the
     highest impact in cases of positive margins. (LE 1)
   In patients with pathological tumour stage T2-3N0M0, salvage
    irradiation is indicated in case of persisting PSA or biochemical
    failure, but before the PSA level rises above 0.5 ng/mL. (LE 3)


   In locally advanced prostate cancer T3-4 N0 M0, concomitant and
    adjuvant hormonal therapy for a total duration of 3 years, with
    external beam irradiation, is recommended because it improves
    overall survival. (LE 1)
Experimental therapeutic options to
treat clinically localized PCa
    All other minimally invasive treatment options - such as HIFU
     microwave and electrosurgery - are still experimental or
     investigational. For all of these procedures, a longer follow-up is
     mandatory to assess their true role in the management of PCa.
Intermittent versus continuous ADT

    Overall, eight randomized trials are underway the largest trial
     available so far(still unpublished)has been presented at several
     meetings.
    A total of 1,386 patients relapsing after radiotherapy, given as either
     primary treatment or for relapsing patients after surgery, were
     randomized to continuous ADT or intermittent ADT.
    Continuous treatment was for a fixed 8-month period.
    Intermittent ADT was stopped when PSA < 4 ng/mL and resumed
     when above 10 ng/mL. After a median 7 years of follow-up, the
     median OS was 9.1 years in the continuous arm and 8.8 years in the
     intermittent arm
   This finding suggests that, even if continuous treatment provides a
    specific survival difference compared to IAD, the survival difference
    is completely counterbalanced by the increased specific toxicity of
    continuous ADT
   which therefore results in a lack of difference in OS survival, the
    increasing of which remains the main objective
BIOCHEMICAL FAILURE AFTER
TREATMENT WITH CURATIVE INTENT
    A recurrence of Ca P can be defined as:
   •Following RP,PSA values > 0.2 ng/mL confirmed by two consecutive
 measures.
    •Following radiotherapy, a PSA value of 2 ng/mL above the nadir
 after radiotherapy.
Diagnostic procedures for PSA
relapse following RP
    bone scintigraphy and CT scans are of no additional diagnostic
     value, unless the PSA serum levels are higher than 20 ng/mL or the
     PSA velocity is more than 20 ng/mL/year.
    Endorectal coil imaging is a useful technique to detect local
     recurrences after RP .In a series of 48 patients, local recurrence was
     correctly identified in 81%, with the mean PSA being 2 ng/mL at
     diagnosis
    Although eMRI appears to be very sensitive and predictive in
     identifying local recurrences following RP, it is currently not a routine
     imaging modality to be performed in every case, as local versus
     systemic relapse must be differentiated at PSA levels < 0.5 ng/mL At
     this PSA level, eMRI is not sufficiently sensitive or accurate.
   Local recurrences are best treated by salvage radiation therapy
    with 64-66 Gy at a PSA serum level < 0.5 ng/mL.


   For patients with presumed local recurrence who are too unfit or
    unwilling to undergo radiation therapy, expectant management
    can be offered.


   PSA recurrence indicative of systemic relapse is best treated by
    early ADT resulting in decreased frequency of clinical metastases.
Castration resistant prostate cancer

    Cancer of the prostate is a heterogeneous disease. Our knowledge
     of the mechanisms involved in androgen independence, which is
     now known as castration-resistant prostate cancer (CRPC), remains
     incomplete but is starting to become clearer .


    It is thought that androgen independence (now called castration
     resistance) is mediated through two main, overlapping,
     mechanisms, which are androgen-receptor (AR)-independent and
     AR-dependent.
   It is recommended to stop anti-androgen therapy once PSA
    progression is documented.
   No clear-cut recommendation can be made for the most effective
    drug for secondary hormonal.
   According to the positive results of this prospective randomised
    clinical phase III trial (LE: 1), cabazitaxel should be considered in the
    management of progressive CRPCA following docetaxel therapy.
   Based on this second positive trial, in patients with relapse following
    first-line docetaxel chemotherapy both Cabazitaxel and
    Abiraterone are regarded as first-choice options for second-line
    treatment
Thank you

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Prostate cancer update

  • 2. Don’t judge the presenter judge the material
  • 3. Gleason score  The Gleason score is the sum of the two most common patterns (grades 1-5) of tumour growth found. The Gleason score ranges between 2 and 10, with 2 being the least aggressive and 10 the most aggressive.  In needle biopsies, the worst grade should always be incorporated in the Gleason score, even if comprising < 5% of the cancer.  During the past 20 years, there appears to have been a shift towards higher Gleason scoring levels ,even in cases evaluating microscopic foci of PCa. Some tumours previously given a Gleason score of 6 (3 + 3) might be scored today as 7 (3 + 4) or higher.
  • 4. SCREENING AND EARLY DETECTION  Based on the results of these two large, randomised trials, (PLCO) (ERSPC) most if not all of the major urological societies conclude that at present widespread mass screening for PCa is not appropriate. Rather, early detection (opportunistic screening) should be offered to the well-informed man  Two key questions remain open: • At what age should early detection start? • What is the screening interval for PSA and DRE?
  • 5. A baseline PSA determination at age 40 years has been suggested, upon which the subsequent screening interval may then be based (GR: B).  A screening interval of 8 years might be enough in men with initial PSA levels <1 ng/mL .  PSA testing in men older than 75 years is not recommended because its early detection would not have any clinical impact .
  • 6. DIAGNOSIS  The main diagnostic tools to obtain evidence of PCa include DRE, serum concentration of PSA and transrectal ultrasonography (TRUS). Its definite diagnosis depends on the histopathologic verification of adenocarcinoma  Sextant biopsy is no longer considered adequate. At a glandular volume of 30-40 mL, at least eight cores should be sampled. The British Prostate Testing for Cancer and Treatment Study has recommended 10 core biopsies (LE: 2a)  More than 12 cores are not significantly more conclusive (LE: 1a)
  • 7. Endorectal MRI (e-MRI)  may allow for more accurate local staging as Image quality and localization improves significantly with e-MRI , When compared with DRE and TRUS.
  • 8. e-MRI contributes significant incremental value for local PCa staging ,particularly in the pre-operative identification of extraprostatic extension (EPE) and seminal vesicle invasion (SVI).  e-MRI could impact on the decision to preserve or resect the neurovascular bundle (NVB) at the time of radical surgery
  • 9. TREATMENT: DEFERRED TREATMENT  There is a great difference between the incidence of PCa and deaths from Pca  Several autopsy studies of people dying from different causes have shown that while 60-70% of older men have histological PCa, a large proportion of these tumours will not progress.  The incidence of small, localised, well-differentiated PCa is increasing, mainly as a result of prostate-specific antigen (PSA) screening and ‘multicore’ schemes of prostate biopsy
  • 10. These data suggest that many men with localised PCa would not actually benefit from definitive treatment.  With the aim of reducing the risk of overtreatment in this subgroup of patients, two conservative management strategies of ‘watchful waiting’ and ‘active surveillance’ have been proposed.
  • 11. Watchful waiting (WW) localised PCa (stage T1-T2, Nx-N0, M0)  the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) randomised 695 patients with clinical stage T1-T2 to WW (348) or radical prostatectomy (347) .  This study began after PSA screening was introduced into clinical practice, but only 5% of men were diagnosed by screening.
  • 12. After a median follow-up of 12.8 years, this study showed a significant decrease in cancer-specific mortality, overall mortality, metastatic risk progression and local progression in patients treated with radical prostatectomy versus WW (LE: 1b).  Subgroup analysis showed that the overall difference was not modified by PSA level (below or above 10 ng/mL) or by the Gleason score (below 7 or above) at the time of diagnosis.  However, age at that the time of randomisation had a profound impact, the benefit on overall survival and metastases free survival being only seen for those below 65 years of age.
  • 13. The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT) is an ongoing, controlled, multicentre, randomised clinical trial comparing radical prostatectomy with WW in patients with clinical stage T1-T2 disease.  731 patients with a median age of 67 years were enrolled.  approximately 43% of men had low-risk PCa, 36% had medium-risk PCa, and 20% had high-risk PCa.  Follow-up is planned for 15 years, and the primary endpoint is the overall mortality.
  • 14. Preliminary unpublished results have been presented at the latest AUA meeting .  The results suggested that overall there was a lack of survival benefit.  However, there appeared to be an overall survival benefit in men with an intermediate- and high-risk PCa, as well as a cancer specific survival benefit in men with high-risk PCa or with a PSA above 10 ng/mL.  It appears that many small localised well-differentiated PCas will not progress, and radical therapy may lead to substantial overtreatment with resulting effects on the patients’ quality of life and treatments costs.
  • 15. Active surveillance  A variety of additional studies on active surveillance in clinically organ confined disease have now been published.
  • 16. All have confirmed that, in well-selected patients with very low-risk disease, there was a very low rate of progression and cancer- specific death, with only a few patients required delayed radical intervention.  However, an extended follow-up is necessary to obtain definitive results.  Thus, active surveillance might mean no treatment at all for patients older than 70 years, while in younger patients, it might mean a possible treatment delayed for years.
  • 17. Indications  Stage T1a: well and moderately differentiated tumours. In younger patients with a life expectancy of more than 10 years, re-evaluation with PSA, TRUS and biopsies of the prostatic remnant is recommended. (LE 2a)  Stage T1b-T2b: well and moderately differentiated tumours. In asymptomatic patients with a life expectancy of < 10 years. (LE 2a)  In patients with the lowest risk of cancer progression: T1-2a, PSA <10 ng/mL, biopsy Gleason score <6 (at least 10 cores), <2 positive biopsies, minimal biopsy core involvement (<50% cancer per biopsy). (LE 2a)
  • 18. Active surveillance selection is based on confirmatory biopsies.  Follow-up is based on DRE, PSA and repeated biopsies. The optimal timing for follow-up is still unclear (yearly or every 2 years).  The trigger for patients being moved off active treatment is based mainly on grade progression on repeated biopsies or at the patient’s request.
  • 19. ACTIVE MANAGMENT  Management decisions should be made after all treatments have been discussed by a multidisciplinary team (including urologists, radiation oncologists, medical oncologists and radiologists), and after the balance of benefits and side effects of each therapy modality has been considered by the patients with regard to their own individual circumstances.  Patient must be informed about the likelihood of a multimodal approach. In case of adverse tumour characteristics (positive section margin, extraprostatic extension, or seminal vesicle invasion), adjuvant radiotherapy may reasonably be used after recovery from surgery.  When nodal involvement is detected after surgery, adjuvant ADT may be selected.
  • 20. When it comes to Pca treatment it is a matter of perspective
  • 21. RADICAL PROSTATECTOMY  While it is the recommended choice In patients with low and intermediate risk localised PCa (cT1a-T2b and Gleason score 2-7 and PSA <20 ng/mL) and life expectancy > 10 years. (LE1b)  It is optional in Patients with stage T1a disease and a life expectancy >15 years or Gleason score 7. (LE 3)  Selected patients with low-volume, high-risk, localised PCa (cT3a or Gleason score 8-10 or PSA > 20 ng/mL). (LE 3)  Highly selected patients with very-high-risk, localised PCa (cT3b-T4 N0 or any T N1) in the context of multimodality treatment.
  • 22. neoadjuvant and adjuvant hormonal treatment and radical prostatectomy  NHT before RP does not provide a significant OS advantage over prostatectomy alone.  NHT before RP does not provide a significant advantage in DFS over prostatectomy alone.  NHT before RP does substantially improve local pathological variables such as organ-confined rates, pathological down-staging, positive surgical margins, and rate of lymph node involvement.  Adjuvant HT following RP shows no survival advantage at 10 years.  Adjuvant HT following RP: the overall effect estimate for DFS is highly significantly in favour of the HT arm.
  • 23. DEFINITIVE RADIATION THERAPY  There are no randomised studies comparing radical prostatectomy (RP) with either external beam radiation therapy (EBRT) or brachytherapy for localised PCa.  However, the National Institutes of Health (NIH) consensus set up in1988 remains available: external irradiation offers the same long- term survival results as surgery.  moreover, EBRT provides a QoL at least as good as that provided by surgery.  Intensity modulated radiotherapy (IMRT) +/- image guided (IGRT) is the gold standard .
  • 24. three-dimensional conformal radiotherapy (3D-CRT)  Anatomical data, acquired by scanning the patient in a treatment position, are transferred to the 3D treatment planning system, which visualises the clinical target volume and then adds a (surrounding) safety margin. At the time of irradiation,  Intensity modulated radiotherapy(IMRT)  enables radiation oncologists to increase radiation doses, up to as much as 86 Gy within the target volume, while respecting the tolerance doses in organs at risk. Certainly, IMRT is the only safe means of treatment delivery for dose escalation beyond 75 Gy
  • 25. Immediate and delayed post-operative external irradiation after radical prostatectomy  Three prospective randomised trials have assessed the role of immediate post-operative radiotherapy  The EORTC study 22911  The study concludes that immediate post-operative radiotherapy after surgery significantly improved 5-year clinical or biological survival: 72.2% versus 51.8% (p < 0.0001)  Also the ARO trial 96-02 and the SWOG 8794 trial with similar conclusion
  • 26. Either immediate radiotherapy (ART) to the surgical bed upon recovery of urinary function ; or clinical and biological monitoring followed by salvage radiotherapy (SRT) before the PSA exceeds 0.5 ng/mL .  Early salvage radiotherapy provides the possibility of cure to patients with an increasing or persisting PSA after RP.  More than 60% of patients who are treated before the PSA level rises to more than 0.5 ng/mL will achieve an undetectable PSA level again
  • 27. Recommendations regarding radiation therapy  In localized prostate cancer T1c-T2c N0 M0, 3D-CRT with or without IMRT is recommended, even for young patients who refuse surgical intervention. (LE 2)  For high-risk patients, long-term ADT prior to and during radiotherapy is recommended because it results in increased overall survival.(LE 2)  In patients with pathological tumour stage T3 N0 M0, immediate post-operative external irradiation after RP may improve overall survival and biochemical and clinical disease-free survival with the highest impact in cases of positive margins. (LE 1)
  • 28. In patients with pathological tumour stage T2-3N0M0, salvage irradiation is indicated in case of persisting PSA or biochemical failure, but before the PSA level rises above 0.5 ng/mL. (LE 3)  In locally advanced prostate cancer T3-4 N0 M0, concomitant and adjuvant hormonal therapy for a total duration of 3 years, with external beam irradiation, is recommended because it improves overall survival. (LE 1)
  • 29. Experimental therapeutic options to treat clinically localized PCa  All other minimally invasive treatment options - such as HIFU microwave and electrosurgery - are still experimental or investigational. For all of these procedures, a longer follow-up is mandatory to assess their true role in the management of PCa.
  • 30. Intermittent versus continuous ADT  Overall, eight randomized trials are underway the largest trial available so far(still unpublished)has been presented at several meetings.  A total of 1,386 patients relapsing after radiotherapy, given as either primary treatment or for relapsing patients after surgery, were randomized to continuous ADT or intermittent ADT.  Continuous treatment was for a fixed 8-month period.  Intermittent ADT was stopped when PSA < 4 ng/mL and resumed when above 10 ng/mL. After a median 7 years of follow-up, the median OS was 9.1 years in the continuous arm and 8.8 years in the intermittent arm
  • 31. This finding suggests that, even if continuous treatment provides a specific survival difference compared to IAD, the survival difference is completely counterbalanced by the increased specific toxicity of continuous ADT  which therefore results in a lack of difference in OS survival, the increasing of which remains the main objective
  • 32. BIOCHEMICAL FAILURE AFTER TREATMENT WITH CURATIVE INTENT  A recurrence of Ca P can be defined as: •Following RP,PSA values > 0.2 ng/mL confirmed by two consecutive measures. •Following radiotherapy, a PSA value of 2 ng/mL above the nadir after radiotherapy.
  • 33. Diagnostic procedures for PSA relapse following RP  bone scintigraphy and CT scans are of no additional diagnostic value, unless the PSA serum levels are higher than 20 ng/mL or the PSA velocity is more than 20 ng/mL/year.  Endorectal coil imaging is a useful technique to detect local recurrences after RP .In a series of 48 patients, local recurrence was correctly identified in 81%, with the mean PSA being 2 ng/mL at diagnosis  Although eMRI appears to be very sensitive and predictive in identifying local recurrences following RP, it is currently not a routine imaging modality to be performed in every case, as local versus systemic relapse must be differentiated at PSA levels < 0.5 ng/mL At this PSA level, eMRI is not sufficiently sensitive or accurate.
  • 34. Local recurrences are best treated by salvage radiation therapy with 64-66 Gy at a PSA serum level < 0.5 ng/mL.  For patients with presumed local recurrence who are too unfit or unwilling to undergo radiation therapy, expectant management can be offered.  PSA recurrence indicative of systemic relapse is best treated by early ADT resulting in decreased frequency of clinical metastases.
  • 35. Castration resistant prostate cancer  Cancer of the prostate is a heterogeneous disease. Our knowledge of the mechanisms involved in androgen independence, which is now known as castration-resistant prostate cancer (CRPC), remains incomplete but is starting to become clearer .  It is thought that androgen independence (now called castration resistance) is mediated through two main, overlapping, mechanisms, which are androgen-receptor (AR)-independent and AR-dependent.
  • 36. It is recommended to stop anti-androgen therapy once PSA progression is documented.  No clear-cut recommendation can be made for the most effective drug for secondary hormonal.  According to the positive results of this prospective randomised clinical phase III trial (LE: 1), cabazitaxel should be considered in the management of progressive CRPCA following docetaxel therapy.  Based on this second positive trial, in patients with relapse following first-line docetaxel chemotherapy both Cabazitaxel and Abiraterone are regarded as first-choice options for second-line treatment